GDC-0152

Iris Chan, M.D., Ph.D.

The study consists of two stages. In Stage 1, maximum tolerated dose (MTD) will be determined. In Stage 2, additional patients will be treated at the MTD of GDC-0152.

A Study of the Safety and Pharmacokinetics of GDC-0152, Administered Intravenously to Patients With Locally Advanced or Metastatic Malignancies

A Phase Ia, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of GDC-0152, an IAP Protein Antagonist, Administered Intravenously to Patients With Locally Advanced or Metastatic Malignancies

Genentech, Inc.

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

CUDC-427 as an oral formulation administered daily on a 14 days on/7 days off schedule

CUDC-427

This is a phase I, open-label, dose-escalation study of CUDC-427 in patients with advanced or refractory solid tumors or lymphoma. CUDC-427 is a drug that is designed to antagonize proteins that prevent or interfere with cell death. The study is designed to assess the safety, including the maximum tolerated dose, the pharmacokinetics, and the anti-cancer activity of CUDC-427.

This is a Phase I, open-label, multicenter, dose-escalation study to evaluate the safety and tolerability of CUDC-427 as a single agent administered orally, in subjects with advanced and refractory solid tumors or lymphoma.

Sequential dose escalation cohorts of oral CUDC-427 are planned. Subject enrollment and dose escalation will proceed according to a standard 3+3 design. In the absence of intolerable toxicity, each subject will receive a minimum of 1 cycle (21 days) of study treatment, and may continue to receive additional cycles until disease progression has been documented or other treatment discontinuation criteria have been met.

No intrasubject dose escalation will be allowed. During the dose escalation phase, up to 3 additional subjects may be enrolled at previously cleared dose levels to better define the safety, tolerability and activity of the study treatment. Similarly, an MTD expansion cohort of up to 12 evaluable subjects may also be enrolled.

Safety and tolerability will be assessed by the incidence and severity of adverse events as assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE v4.03). A Safety Review Committee comprised of the Medical Monitor, Principal Investigators, and Sponsor representatives, will be convened to review safety information and to decide upon dose escalation and further subject enrollment.

The antitumor activity of study treatment will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or the Revised Response Criteria for Malignant Lymphoma as appropriate for each subject's tumor type.

Exploratory biological markers of CUDC-427 activity will be assessed in tumor samples (where available), peripheral blood mononuclear cells (PBMC) and plasma.

Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of CUDC-427 When Given to Patients With Advanced and Refractory Solid Tumors or Lymphoma

A Phase I Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral CUDC-427, an Antagonist of Inhibitors of Apoptosis (IAP) Proteins, When Administered in Subjects With Advanced and Refractory Solid Tumors or Lymphoma

Number of participants with adverse events assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE, v4.0).

PK parameters to be determined will include apparent oral clearance (Cl/F), apparent volume of distribution (Vd/F), maximum concentration (Cmax), time of maximum concentration (Tmax), half-life (t1/2), area under the curve (AUC), and other relevant parameters.

Exploratory biomarkers that may predict or correlate with CUDC-427 biological activity will be assessed in tumor samples, PBMCs and plasma, such as gene signature profile, cellular inhibitor of apoptosis (cIAP) levels, Ki-67 activity, caspase activity, cytokine levels, and other downstream events of IAP inhibition.

The Investigator will evaluate each subject for response to therapy according to standard response criteria for each individual subject's tumor type (e.g., Revised Response Criteria for Malignant Lymphoma and RECIST v1.1 for Solid Tumors).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of the Safety and Pharmacokinetics of GDC-0152, Administered Intravenously to Patients With Locally Advanced or Metastatic Malignancies	NCT00977067	Solid Cancers	GDC-0152	18 Years -	Genentech, Inc.
A Study of the Safety and Pharmacokinetics of GDC-0152, Administered Intravenously to Patients With Locally Advanced or Metastatic Malignancies	NCT00977067	Solid Cancers	GDC-0152	18 Years -	Genentech, Inc.
Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of CUDC-427 When Given to Patients With Advanced and Refractory Solid Tumors or Lymphoma	NCT01908413	Lymphoma	CUDC-427	18 Years -	Curis, Inc.
Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of CUDC-427 When Given to Patients With Advanced and Refractory Solid Tumors or Lymphoma	NCT01908413	Lymphoma	CUDC-427	18 Years -	Curis, Inc.

Spots Global Cancer Trial Database for iap

Every month we try and update this database with for iap cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for iap

Every month we try and update this database with for iap cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for iap cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.